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AAT + Corticosteroids for Graft-versus-Host Disease

Phase 3

Waitlist Available

Research Sponsored by CSL Behring

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any graft or donor source or conditioning intensity

Initial presentation of acute GVHD after allogeneic hematopoietic cell transplantation for any indication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post-randomization

Awards & highlights

Study Summary

This trial will compare the effectiveness of a combination of AAT and corticosteroids to corticosteroids alone as the first treatment for patients at high risk for developing acute GVHD.

Who is the study for?

This trial is for patients aged 12 or older who have acute GVHD after a stem cell transplant and need systemic therapy with corticosteroids. It's not for those previously treated with AAT, having cancer that's returned or not responding to treatment, using steroids within the last week before GVHD onset, or currently on other drugs for GVHD.Check my eligibility

What is being tested?

The study compares two treatments for acute GVHD: one group receives Alpha-1 antitrypsin (AAT) plus corticosteroids, while the other gets a placebo alongside corticosteroids. The goal is to see if adding AAT improves outcomes.See study design

What are the potential side effects?

Possible side effects of AAT may include allergic reactions at the injection site, headaches, dizziness, nausea and vomiting. Corticosteroids can cause increased appetite, mood changes, high blood pressure and higher risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a transplant from any donor or undergone any intensity of preparation treatment.

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I have acute GVHD after a stem cell transplant.

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I have acute GVHD and need steroids for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent of participants with complete or partial response to acute Graft-versus-Host Disease (GVHD) treatment

Secondary outcome measures

Duration of response (DOR)

Percent of participants with GVHD-free survival

Percent of participants with Grade 2 to 3 systemic infections

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AATExperimental Treatment1 Intervention

Alpha-1 antitrypsin (AAT) is a lyophilized powder for intravenous administration

Group II: PlaceboPlacebo Group1 Intervention

Albumin solution administered intravenously

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,452 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,017 Total Patients Enrolled

1 Trials studying Graft-versus-Host Disease

236 Patients Enrolled for Graft-versus-Host Disease

Blood and Marrow Transplant Clinical Trials NetworkNETWORK

49 Previous Clinical Trials

13,846 Total Patients Enrolled

Media Library

Alpha-1 antitrypsin (AAT) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04167514 — Phase 3

Graft-versus-Host Disease Research Study Groups: Placebo, AAT

Graft-versus-Host Disease Clinical Trial 2023: Alpha-1 antitrypsin (AAT) Highlights & Side Effects. Trial Name: NCT04167514 — Phase 3

Alpha-1 antitrypsin (AAT) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04167514 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has AAT been cleared by the FDA for therapeutic use?

"There is some evidence for AAT's efficacy and it has undergone multiple rounds of testing, so it has been deemed safe and given a score of 3."

Answered by AI

Can patients still sign up for this program?

"The listed clinical trial on clinicaltrials.gov is still recruiting patients. This trial was originally posted on 2020-01-09 and was most recently updated on 2022-08-12."

Answered by AI

How many individuals are being treated in this clinical trial?

"The study requires a total of 122 participants that fit the inclusion criteria. The sponsor, CSL Behring, will administer the trial from their locations in Richmond, Virginia and Ann Arbor, Michigan."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone (BMT CTN 1705)

2020. "Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone (BMT CTN 1705)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04167514.

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